Associate Quality Engineer

Job description

DePuy Synthes Companies of Johnson & Johnson is recruiting for an Associate Quality Assurance Engineer to be located in Elmira, NY.

DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopedic and neurological business in the world. DePuy Synthes Companies will offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, we are creating one organization that will be agile and better equipped in today's evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own. The Associate Quality Assurance Engineer will:

· Develop, implement and maintain Quality System requirements on assigned areas of manufacturing, supplier management, and process validation.
· Areas of responsibility may include: non-conforming product, CAPA, calibration systems, supplier auditing, sterility assurance, and improving measuring techniques, design of gages, training, statistical support, quality planning, experimental protocols, and facilitation of root cause analysis, risk assessment and complaint investigation
· Know and follow all laws and policies that apply to one's job and maintain the highest levels of professionalism, ethics and compliance at all times.
· Diligently participate in our compliance program- related activities as denoted by your supervisor or our Chief Compliance Officer
· Be a member of the Material Review Board (MRB).
· Communicate and resolve quality issues and apply root cause analysis to drive corrective and preventive actions.
· Work on continuous improvement activities.
· These may include participating in, and/or leading Quality Improvement Teams.
· Provide quality reports and review trending on assigned areas of responsibility.
· Conduct failure investigations and problem analysis regarding customer complaints, stock evaluations, supplier quality issues, calibration out of tolerance conditions, and CAPAs (internal or audit CAPAs).
· Review and approve documents and drawings for manufacturing and product development (DCOs, MCs).
· Support to Engineering, Manufacturing, Materials, Inspection, Distribution and/or Product Development Groups in order to assure quality and compliance of products.
· Participate on cross- functional project teams.
· Design gauging and develop tools and techniques to measure product parameters to assure product complies with engineering drawings.
· Recommend, acquire and validate the necessary tools, equipment and technologies to support inspection and testing activities.
· Develop and document Quality Plans to support product acceptance activities.
· Facilitate creation of risk management documents.
· Ensure compliance issues are addressed for product activities.
· Participate on design reviews and risk analysis for product changes.
· Provide process validation program oversight to ensure adequacy of validation activities and documentation in terms of regulatory compliance and technical/statistical soundness.
· Review, assess and evaluate validation protocols (IQ, OQ, PQ) for compliance to procedures and regulations, statistical validity and approval.
· Provide guidance to others for the generation of clear, concise and defendable protocols and reports.
· Assist in determination of the need for validation.
· Generate and/or maintain internal validation master plans as required.
· Manage process monitoring activities including tracking, data collection and analysis, corrective action, and reporting.
· Manage supplier validation activities including supplier assessment, protocol development, and generation of supplier validation master plan(s).
· Lead continuous improvement activities for the validation program to ensure efficiency, effectiveness and compliance.
· Coordinate and participate on supplier audits and technical assessments.
· Assist purchasing with identification and qualification of suppliers and alternate manufacturing locations.
· Administrate Supplier Management Program and measures effectiveness.
· Manage Supplier CAPA activities including root cause analysis, definition of corrective actions and verification of actions.
· Coordinate Quality Plans and inspection/test methods between suppliers and Synthes.
· Visit suppliers for the purpose of quality issues investigation and capability analysis.
· Assist purchasing in resolution of supplier complaints.

Desired profile

Preferred Qualifications:

·  A Bachelors Degree
·  A minimum of 1 year (professional, internship, co-op, etc.) experience working in a quality system framework (ISO 9001 or similar)
·  Medical device/diagnostic/or pharmaceutical industry experience
·  Knowledge of FDA's QSR and ISO regulations
·  Working knowledge of Geometric Dimensioning and Tolerancing, Blueprint Reading, Basic Metrology, Gage design, Design/Process FMEA and Quality Plan Development
·  Knowledge of Gage Repeatability and Reproducibility, Statistical Process Control, Process Capability and Design of Experiments
·  ASQ Certified Quality Engineer, Lean Manufacturing and/or Six Sigma certification
·  Knowledge of Manufacturing materials and removal processes (machining, sheet metal, electro polishing, passivation, hard coating, cleaning, adonization, etc.)

Required Qualifications:
·  A minimum of an Associate's degree in Sciences, Business, Engineering or related technical field with experience in a highly regulated matrixed environment.
·  Ability to manage multiple projects/requirements in a fast-paced environment.
·  This position will be located in Elmira, NY and may require up to 10% travel including potential international travel.